BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

    MDR report key: 300588 · Received October 13, 2000

    Report

    Report Number
    1527736-2000-05035
    Event Type
    Malfunction
    Date Received
    October 13, 2000
    Date of Event
    September 13, 2000
    Report Date
    September 18, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) EMS WAS USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. IT WAS REPORTED THAT WHEN THE DEVICE WAS FIRED, THE STAPLES DID NOT FORM, THE LEGS WERE STILL STRIAGHT NO "B" FORMATION. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIFEED STAPLER STAPLERS - ENDOSCOPIC GAG ETHICON ENDO-SURGERY, INC. NA N4HJZ1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other